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Randomized Controlled Trial of Different Antibiotic Duration Prior to Prostate Enucleation Surgery

Randomized Controlled Trial of 3 vs 7 Days for Perioperative Antibiotic Prophylaxis for Patients With an Indwelling Catheter Prior to Holmium Laser Enucleation of the Prostate

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07209150
Enrollment
250
Registered
2025-10-06
Start date
2026-01-01
Completion date
2028-07-15
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Prophylaxis, BPH With Urinary Obstruction

Keywords

bph, urinary retention, antibiotic prophylaxis

Brief summary

To compare the risk of infectious complications (UTI, pyelonephritis, sepsis, hospital admission, ED visits) for patients with an indwelling urinary catheter (urethral or suprapubic) or CIC receiving 3 or 7 days of peri-operative antibiotic prophylaxis at time of Holmium Laser Enucleation of the Prostate

Interventions

DRUGantibiotic prophylaxis

we will compare varying durations of antibiotic prophylaxis prior to prostate enucleation surgery

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Patients who are eligible to undergo HoLEP and have an indwelling urinary catheter or perform CIC will be randomized to different durations of peri-operative antibiotic prophylaxis

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 1\. Candidate for HoLEP surgery 2. Must be 18 years or older. 3. The patient must be able to understand and willing to provide informed consent as described in this study protocol.

Exclusion criteria

* 1\. Under the age of 18 2. Refuse to provide informed consent 3. Anticipated need for perineal urethrostomy 4. History of multi-drug resistant organism on urine culture that is not susceptible to any oral agents

Design outcomes

Primary

MeasureTime frameDescription
Infectious complications0-90 days postoperativelyUTI, pyelonephritis, sepsis, hospital admission, ED visits

Secondary

MeasureTime frameDescription
healthcare utilization0-90dayshospital admission or ED visits occurring post HoLEP

Contacts

Primary ContactMatthew Lee, MD
matthew.lee@osumc.edu614-293-8155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026